Prosecutors target Russian clinic testing British firm's MMR vaccine

Russian prosecutors have opened a criminal investigation into a clinic after unsubstantiated allegations that a vaccine made by the British drugs company GlaxoSmithKline has had disturbing side effects in a clinical trial. Prosecutors in Volgograd are investigating a clinic that tested the chickenpox, measles, mumps and rubella vaccine on 100 babies between the ages of one and two.

Prosecutors say at least one of the children developed alarming symptoms after receiving the vaccine. A regional court last week halted the trial, by the city's Independent clinical hospital, amid complaints from parents that they had not been fully informed they were taking part in an experiment.

It follows complaints by the family of Vika Gerasinka, who was given the GlaxoSmithKline vaccine in November 2005. Her family claim that before receiving the shots she was developing normally, and was able to say 10 words. Afterwards, however, they allege that she became fretful and developed problems.

"Since getting her shots, Vika and I have been to the hospital on several occasions. She has frequently been sick," her grandmother, Lyubov Gerasinka, said. Vika, now two and a half, had serious speech and psychological problems, she added.

Yesterday GlaxoSmithKline, the world's second biggest pharmaceutical company, said the vaccines in the trial were entirely safe and had been extensively tested.

The clinical trial involved 5,700 adults and children in 10 European countries including Russia, a spokeswoman said. All three vaccines - Varilrix, against chickenpox; Priorix-Tetra, a combined MMR and chickenpox vaccine; and Priorix, a new MMR vaccine - had been approved by European and Russian regulators.

"GlaxoSmithKline is extremely concerned about the unsubstantiated and untrue allegations circulating relating to clinical trials in Russia," Michael Crow, the firm's Russia vice-president, told the Guardian. He said an internal audit had found "no signs of misconduct" by the private Volgograd clinic. There was also no evidence to link Vika Gerasinka's problems with the MMR vaccine, he added.

The clinic received $50,000 (£25,500) from the British drugs company to carry out the trial, prosecutors say. The Rossiskaya Gazeta newspaper cited local doctors as saying one of the problems with the trial may have been the fact that so few babies were healthy in the first place.

Yesterday a spokeswoman for the Volgo-grad prosecutor's office said the criminal case was against the clinic and not GlaxoSmithKline. "GlaxoSmithKline contracted the clinic, so the clinic was responsible," Lidia Sergeyeva said. She made clear, though, that future action against the drug maker was not impossible.